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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05802485
Other study ID # PANDORE-PANC-IPC 2021-082
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 30, 2023
Est. completion date February 1, 2029

Study information

Verified date March 2023
Source Institut Paoli-Calmettes
Contact Dominique GENRE, MD
Phone +33491223778
Email drci.up@ipc.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study consists of a 25 ml blood sample collection: - Before the start of treatment - Approximately 2 months after the start of induction chemotherapy - At the end of induction chemotherapy - Prior to local treatment (radiotherapy, surgery) - At the time of tumor progression Collection of tumor material: - During the initial diagnostic biopsy - On the operating room in case of surgery - At tumor biopsy in case of recurrence or progression (optional) As well as the completion of a questionnaire at inclusion.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date February 1, 2029
Est. primary completion date February 1, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Non-metastatic pancreatic adenocarcinoma that is not immediately resectable (borderline and locally advanced tumors according to the NCCN 2020 classification) - No previous treatment with surgery or chemotherapy - Age > 18 years - General condition WHO 0-2 (patient whose general condition can allow medical treatment or surgery) - Therapeutic management at the Paoli-Calmettes Institute - Signature of the informed consent specific to the PANDORE-PANC study - Patient affiliated to a social security system or benefiting from such a system Exclusion Criteria: - Metastatic disease - Pancreatic tumor of a histological type other than adenocarcinoma - Other tumor under treatment or for which treatments have been completed for < 1 year - Pregnant or breastfeeding women - Person in an emergency situation - Person of legal age under legal protection (guardianship, curatorship or safeguard of justice) or unable to give consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
collection of blood and tumor samples
The study consists of the collection of a 25 ml blood sample: Before the start of treatment Approximately 2 months after the start of induction chemotherapy At the end of induction chemotherapy Prior to local treatment (radiotherapy, surgery) At the time of tumor progression At the time of collection of tumor material: During the initial diagnostic biopsy On the operating room in case of surgery During a tumor biopsy in case of recurrence or progression (optional) and a questionnaire evaluating the patient's spontaneous physical activities.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institut Paoli-Calmettes

Outcome

Type Measure Description Time frame Safety issue
Primary Predict response to systemic therapies in patients with non-metastatic pancreatic adenocarcinoma Analysis of the impact of identified biomarkers on overall patient survival and tumour response up to 6 years
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